Gemifloxacin: profile and news






Oscient Pharmaceuticals Reports Financial Results for Fourth ...  07 Mar 2006
During the fourth quarter of 2005, Oscient recorded $8.0 million in revenue from the Company's lead product, FACTIVE(R) (gemifloxacin mesylate) tablets, FDA ... - Genetic Engineering News,

Oscient Pharmaceuticals to Present at Fifth Annual JMP Securities ...  Mar 2, 2006
...and CEO, Steven Rauscher, will provide an overview of the Company including details on the recent sublicense of FACTIVE(R) (gemifloxacin mesylate) tablets in ... - Genetic Engineering News,

Webcast Alert: Oscient Pharmaceuticals Announces Date for Release ...  Feb 22, 2006
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the five-day treatment of acute bacterial exacerbations of chronic ... - Business Wire (press release),

Oscient Pharmaceuticals and Pfizer Enter Agreement for FACTIVE ...  Feb 7, 2006
Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has sublicensed the commercialization rights to FACTIVE(R) (gemifloxacin mesylate) tablets in Mexico to ... - Genetic Engineering News,

Oscient Pharmaceuticals and Pfizer Enter Agreement for FACTIVE ...  Feb 7, 2006
7, 2006 - Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has sublicensed the commercialization rights to FACTIVE(R) (gemifloxacin mesylate) tablets in ... - PharmaLive.com (press release),

Oscient Pharmaceuticals y Pfizer celebran acuerdo por las...  Feb 7, 2006
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic ... - Nosis NyM,

Pfizer acquires rights to Oscient antibiotic in Mexico  Feb 9, 2006
Factive (gemifloxacin mesylate) is currently approved in the US for the treatment of community-acquired pneumonia (CAP) of mild to moderate severity and acute ... - Pharmaceutical Business Review

Robust Viral Load Reduction Successfully Achieved in Phase II ...  Feb 14, 2006
LGLS seeks to continue developing global brand products, such as Factive(R) (gemifloxacin), and expanding its market presence in the world with focus in Asia. ... - PharmaLive.com (press release),

Webcast Alert: Oscient Pharmaceuticals to Present at BIO CEO & ...  09 Feb 2006
...and CEO, Steven Rauscher, will provide an overview of the Company including details on the recent sublicense of FACTIVE(R) (gemifloxacin mesylate) tablets in ... - Genetic Engineering News,

Oscient Pharmaceuticals Provides Preliminary Revenues for Fourth ...  Jan 9, 2006
...quarter revenues of approximately $9.2 million, with approximately $8 million in revenue from its lead product, FACTIVE(R) (gemifloxacin mesylate) tablets, and ... - Genetic Engineering News,

New Data on FACTIVE(R) Tablets and Ramoplanin Presented at the ...  Dec 9, 2005
Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, and lead product candidate ... - Genetic Engineering News,

Oscient Pharmaceuticals to Present at First Albany Capital Annual ...  Nov 29, 2005
...and CEO, Steven Rauscher, will provide an overview of the Company as well as an update on the market performance of FACTIVE(R) (gemifloxacin mesylate) tablets ... - Business Wire (press release),

Clinical Data on FACTIVE(R) Tablets for ABS and AECB Presented at ...  Oct 7, 2005
IDSA) features clinical data on Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets. ... - Genetic Engineering News,

Clinical Data on FACTIVE(R) Tablets to be Presented at the 43rd ...  Sep 30, 2005
Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, is the subject of two poster ... - Genetic Engineering News,

Clinical Data on FACTIVE Tablets to be Presented at the 43rd ...  Sep 30, 2005
BUSINESS WIRE)--Sep 30, 2005 - Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, is ... - PharmaLive.com (press release),

Full Results Released From Phase III Trial Comparing Five-Day and ...  Sep 18, 2005
Data from the study of Oscient Pharmaceuticals' (Nasdaq: OSCI) FDA-approved fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets, for the ... - RedNova.com,

Full Results Released from Phase III Trial Comparing Five-Day and ...  Sep 18, 2005
Data from the study of Oscient Pharmaceuticals' (Nasdaq: OSCI - News) FDA-approved fluoroquinolone antibiotic, FACTIVE® (gemifloxacin mesylate) tablets, for ... - Press Method (press release),

Oscient Pharmaceuticals Completes Sales Force Expansion; Company ...  Oct 3, 2005
The national sales force is focused on promoting Oscient's fluoroquinolone antibiotic, FACTIVE(R) (gemifloxacin mesylate) tablets and Auxilium Pharmaceuticals ... - Business Wire (press release),

Legionnaires' disease - Legionellosis  Oct 6, 2005
The current treatment of choice are the respiratory tract quinolones (levofloxacin, moxifloxacin, gemifloxacin) or newer macrolides (azithromycin ... - Food Consumer,

Oscient Pharmaceuticals Files Shelf Registration Statement  Sep 30, 2005
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic ... - Genetic Engineering News,

Many meds don't mix with the sun  Sep 21, 2005
...dapsone, de-meclocycline (Declomycin), doxycycline (Vibramycin) ethio-namide (Trecator-SC), flucytosine (Ancobon), gemifloxacin (Factive), griseofulvin ... - Pioneer Press,

Oscient Pharmaceuticals to Present at Thomas Weisel Healthcare ...  Sep 2, 2005
...and CEO, Steven Rauscher, will provide an overview of the Company as well as an update on the market performance of FACTIVE(R) (gemifloxacin mesylate) tablets ... - Genetic Engineering News,

Oscient Pharmaceuticals Reports Financial Results for Second ...  Aug 2, 2005
...the Company recorded $4.2 million in total revenue, with $3.8 million from sales of the Company's lead product, FACTIVE (R) (gemifloxacin mesylate) tablets, FDA ... - RedNova.com

Webcast Alert: Oscient Pharmaceuticals Announces Date for Release ...  Jul 19, 2005
The Company is marketing FACTIVE(R) (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic ... - Business Wire (press release) <**results**>

Oscient Pharmaceuticals Achieves Primary Endpoint in Phase III ...  Jun 6, 2005
Nasdaq: OSCI) has completed preliminary data analysis of its pivotal Phase III trial examining the potential use of FACTIVE (R) (gemifloxacin mesylate) tablets ... - Business Wire (press release),


Other information


Indication
For the treatment of Bacterial infection caused by susceptible strains such as S.pneumoniae, H.influenzae, H.parainfluenzae, or M.catarrhalis, S.pneumoniae (including multi-drug resistant strains [MDRSP]), M.pneumoniae, C.pneumoniae, or K.pneumoniae.

Pharmacology
Gemifloxacin is a quinolone/fluoroquinolone antibiotic. Gemifloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase, which allows the untwisting required to replicate one DNA double helix into two. Notably the drug has 100 times higher affinity for bacterial DNA gyrase than for mammalian. Gemifloxacin is a broad-spectrum antibiotic that is active against both Gram-positive and Gram-negative bacteria.

Mechanism Of Action
The bactericidal action of Gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Drug Category
Anti-bacterial Agents; ATC:J01MA15

Brand Names/Synonyms
Factive; Gemifloxacin; Gemifloxacin Mesilate; Gemifloxacin [Inn]

Dosage Forms
TABLET

Absorption
Gemifloxacin is rapidly absorbed from the gastrointestinal tract. The absolute bioavailability of the 320 mg tablet averaged approximately 71% (95% CI 60%-84%).

Interactions
-->Interactions for Gemifloxacin:

Administration of repeat doses of FACTIVE had no effect on the repeat dose pharmacokinetics of theophylline, digoxin or an ethinylestradiol/levonorgestrol oral contraceptive product in healthy subjects.

Concomitant administration of FACTIVE and calcium carbonate, cimetidine, omeprazole, or an estrogen/progesterone oral contraceptive produced minor changes in the pharmacokinetics of gemifloxacin, which were considered to be without clinical significance.

Concomitant administration of FACTIVE with probenecid resulted in a 45% increase in systemic exposure to gemifloxacin.

FACTIVE had no significant effect on the anticoagulant effect of warfarin in healthy subjects on stable warfarin therapy. However, because some quinolones have been reported to enhance the anticoagulant effects of warfarin or its derivatives in patients, the prothrombin time or other suitable coagulation test should be closely monitored if a quinolone antimicrobial is administered concomitantly with warfarin or its derivatives.

Quinolones form chelates with alkaline earth and transition metals. The absorption of oral gemifloxacin is significantly reduced by the concomitant administration of an antacid containing aluminum and magnesium. Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin preparations containing zinc or other metal cations, or Videx (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should not be taken within 2 hours of FACTIVE.



Chemical IUPAC Name
1-acetyloxycyclohexane-1-carboxylicacid

Chemical Formula
C18H20FN5O4

Half Life
7 (+/- 2) hours

Drug Type
Approved Drug

# Accession No
APRD00053

CAS Registry Number
175463-14-6

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